LiquID .051 LP Guide Catheter Extension

The LiquID .051 LP Guide Catheter Extension is a percutaneous catheter designed to be used with guide catheters to access discrete regions of the coronary and peripheral vasculature and facilitate placement of interventional devices. It is a single-use, sterile device with a 150 cm working length featuring a stainless-steel shaft connected to a silicone-coated, single-lumen tube catheter body.

The key difference from the predicate devices (LiquID 061 and 071) is a smaller intraluminal tip inner diameter of 0.051 inches versus 0.061 and 0.071 inches. The subject device shares the same 150 cm working length, single-use designation, ethylene oxide sterilization method, radiopacity features, and stainless-steel construction with coil-reinforced, silicone-coated catheter body.

Not stated in this summary.

The LiquID .051 LP is substantially equivalent because it has identical intended use, method of operation, and design features to the predicate devices, differing only in the distal tip inner diameter (0.051 vs. 0.061/0.071 inches). Performance testing demonstrated acceptable functionality in distal device identification, stent delivery, contrast injection, tensile strength, kink resistance, and trackability, with no new safety or effectiveness concerns raised compared to the predicates.